COPD Medicines: Risky or Safe?
Study Links 2 COPD Drugs to Risks of Heart Attack, Stroke, Death
By
Kathleen Doheny
WebMD Health News
Reviewed By
Louise Chang, MD
Sept. 23, 2008 -- Two commonly used treatments for the lung disease known as
chronic obstructive pulmonary disease (COPD) boost the risk of heart
attack, stroke, or death from cardiovascular causes, according to
a new analysis. But the drugs' marketers sharply disagree.
The medicines under scrutiny are called inhaled anticholinergics, which work
by relaxing the muscles around constricted airways and relieving symptoms such
as shortness of breath.
The use of two commonly prescribed anticholinergics, Spiriva and Atrovent,
for more than a month boosted the risk of heart attack, stroke, or dying of
cardiovascular problems by 58%, says Sonal Singh, MD, MPH, assistant professor
of internal medicine at Wake Forest University School of Medicine in
Winston-Salem, N.C., and lead author of the study, which appears in The
Journal of the American Medical Association.
Singh and colleagues pooled the results of 17 randomized trials that
included nearly 15,000 patients who took the anticholinergics or a control
treatment. "Every study points in the same direction," he tells
WebMD.
Meanwhile, pharmaceutical industry spokespeople issued a statement strongly
disagreeing with the conclusions of the study, issuing their own new analysis
that they say confirms the safety of Spiriva.
COPD Medicines: Study Details
Singh and his colleagues looked at the 17 trials to see if the medicines
increased the risk of heart attack, stroke, and death from cardiovascular
disease or death from other causes.
They found that the COPD medicines increased risk of death from
cardiovascular disease as well as the risk of stroke or heart attack when the
three outcomes were grouped together, but the drugs did not significantly
increase the risk of death from all causes.
While 1.2% of control patients had a heart attack, stroke, or died from
cardiovascular disease during the follow-up (which ranged from six weeks to
five years), 1.8% of those on the anticholinergics did. That accounts for the
58% increase.
When Singh looked at the individual outcomes, rather than as a group, the
increased risk for stroke didn't turn out to be significant, but the risk for
heart attack and death from cardiovascular disease remained so.
The latest research isn't the first to uncover the risk. Atrovent was linked
with a 34% increased risk of cardiovascular death by other researchers, who
published their findings in the Annals of Internal Medicine last
week.
COPD Medicines: Industry's View
Both medications are safe, according to spokespeople from pharmaceutical
companies that market Spiriva and Atrovent.
"Extensive research provides strong support for the safety of these
medications and is contrary to the conclusion expressed in the recently
released articles by Dr. Lee and colleagues [the Annals of Internal
Medicine study] and Dr. Singh and colleagues," says Lara Crissey, a
spokeswoman for Boehringer Ingelheim, which markets Atrovent and jointly
markets Spiriva with Pfizer Inc.
In a statement jointly issued by the companies, officials elaborate on
Spiriva, saying its safety profile is confirmed by 30 clinical trials recently
analyzed by both companies but not yet published.
The statement reads, in part: "The new and expanded safety data
contradicts the conclusions about [Spiriva]" in Singh's review.
Citing "data on file" at Boehringer Ingelheim, the statement says
the analysis of 30 trials involving nearly 20,000 COPD patients, some on
Spiriva, some on placebo, found no increased risk of death from all causes or
from cardiac events nor an increased risk of stroke or heart attack.
The data reviewed, according to the statement, includes information from
findings of a trial called UPLIFT, to be presented in October at a respiratory
society meeting overseas.
Most evidence in the Singh report, the statement also points out, comes from
a single study, the Lung Health Study, which involved Atrovent, not Spiriva,
and that most deaths from cardiovascular disease occurred among patients who
didn't take their medicine.
Singh counters that even after excluding information from the Lung Health
Study, the risks remained.
COPD Medicines: Ask Your Doctor
The results of Singh's review are "troublesome," says Norman
Edelman, MD, chief medical officer of the American Lung Association and
professor of medicine and preventive medicine at Stony Brook University in Long
Island, N.Y. "We use anticholinergics a lot," he says of physicians who
treat the more than 12 million U.S. adults with COPD.
Until recently, he says, research looked good on both COPD medicines.
"Clinical data show people have better lung function on these drugs,
especially Spiriva."
Still, he says, "the study doesn't necessarily mean everyone should go
off these drugs."
Physicians who care for COPD patients, he says, should read the report
carefully and then use their clinical judgment to decide the best
treatment.
Other options for treating COPD include inhaled steroids and
long-acting bronchodilators, he says, or a combination of
treatments. If the COPD is severe, he says, "it is common to take all
three."
For COPD patients, he has this advice: "COPD patients should sit with
their doctors and say, 'Look, I read this [study], I am concerned about
this." Ask the doctor what medicines are best and why, he says.
SOURCES: Singh, S. The Journal of the American Medical Association, Sept. 24,
2008; vol 300: pp. 1439-1450. Sonal Singh, MD, MPH, assistant professor of internal medicine, Wake Forest
University School of Medicine, Winston-Salem, N.C. Sally Beatty, spokeswoman, Pfizer Inc. Lara Crissey, spokeswoman, Boehringer Ingelheim. News release, Boehringer Ingelheim and Pfizer Inc. Norman Edelman, MD, chief medical officer, American Lung Association, New
York; professor of medicine and preventive medicine, Stony Brook University,
Long Island, N.Y. Lee, T. Annals of Internal Medicine, Sept. 16, 2008: vol 149: pp.
380-390.
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